'Manufacturing India-specific medical devices will up cost to patient'

Manufacturing an India-specific line of medical devices and equipment will increase the financial burden on patients and hamper the government's vision of affordable, assessable healthcare for all, experts have warned.ETHealthWorld | December 22, 2016, 05:30 IST

New Delhi, 20th December 2016: Today at a board meeting, members of the Medical Technology Association of India (MTaI) discussed the forecast for 2017 for the medical devices industry in India. While the Government has made progress in many directions, the board thinks, logjams on some key issues pertaining to the industry at the policy level are likely to do irreparable damages that will ultimately impact patients. Deliberations at meeting, underscored some key areas that need immediate attention from the Government:

Sushobhan Dasgupta, Managing Director, Johnson & Johnson Medical and MTaI founding member said, “The move towards creating a separate draft policy on medical devices, the fact that the Government has taken notice that devices are different from drugs, is a very welcome change and much appreciated by the industry. Having said that there are some rules that need further amendments. The first being the 5 year cap on shelf life of medical devices. Here we would like to highlight that devices unlike drugs (which are chemical entities) are more stable and hence restricting the shelf life of devices to 5 years will not be suitable especially the devices made of stable metals. The reason given is that restriction of shelf life is required for ‘Indian conditions’, whereas even more underdeveloped continents like Africa, where the ‘conditions’ are similar or worse as compared to India do not have such a restriction. Since 2006 devices which are regulated are available in the country with a 10 year shelf life. Hence there is no scientific data to backup the ‘Indian conditions’ claim. However we manufacturers claim 10 years shelf life based on stability data. For those devices where a shelf life of 10 years is globally accepted, there is no reason to restrict shelf life to 5 years.”

“The most important question to ask here is that – ‘Whose responsibility is it to ensure that the right storage conditions and the right logistical facilities etc are maintained?’ – It is the responsibility of the law enforcer, which is the Ministry of Health and its regulating agencies, which have done some path breaking work in the current regime. We request the regulator to keep its bar high for Medical Devices too by ensuring better compliance to storage norms and not penalize the medical devices industry for any short falls in their own work” said Pavan Choudary, Director General, MTaI.

“Another rule mentioned by CDSCO is the implementation of UDI (Unique Device Identifier) for medical devices, a regulation that is being rolled-out in a stage-wise process in both the US and EU as per the classification of the device. Hence, asking every medical device to have a UDI from 2017 in India is not feasible as the companies will not be in a position to do so only for India. It would force upon manufacturers to India specific line which will really take the cost of treatment high,” said Probir Das, Managing Director, Terumo India and MTaI Founder Member.

Custom duty on medical devices

“The import duties on medical devices and equipments have been increased almost across the board by 7.3%. Since most of the items affected were falling in the 11.6% range which has gone to 18.9% now, it means an effective duty increase of 62.7%. We would like to highlight the fact that import duties could indeed have been moderately increased (if benchmarking studies or precedent analysis of other countries showed that such a move would further the Make in India program) only for those sub sectors or product categories where a high level of import substitution of an acceptable quality has been obtained or can be obtained quickly. However, this steep custom duty increase has been slapped on almost all sub-sectors/product categories of the medical technology sector irrespective of level or possibility of import substitution in the near term. We wish to underscore that this custom duty increase for most part are only increasing the burden on the patient,” said Pavan Choudary, Director General, MTaI and Managing Director, Vygon India

Only in India the healthcare financing is very small when compared to the financing by the other forces rather than the patient himself or herself paying out of pocket. Having 70-75% of the expenses as out-of-pocket, in my opinion, is not a right approach to managing healthcare in a country where the patients tend to sub-optimally purchase healthcare if he/she has to pay out-of-pocket.